Effect of an Educational Program for Staff in Nursing Homes Concerning Patients Fecal Incontinence: a Cluster-randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Change in frequency of fecal incontinence among patients
研究概览
简要总结
Fecal incontinence (FI) has an increasing prevalence in the geriatric population which cannot be explained by co-morbidity or anatomical and psychological changes of aging alone. In the nursing home population previous studies suggest a prevalence between 10 and 69%, but is most often reported to be between 40 and 55%. FI leads to a high direct and indirect economic burden to the health-care system, and is an important cause og institutionalization of the elderly patients. In addition, FI is associated with shame, social isolation and reduced quality of life.
The importance of identifying treatable causes of FI in the frail elderly, rather than just managing passively, is strongly emphasized. It is indicated that the level of awareness among health personnel regarding appropriate assessment and treatment options is limited, and that FI is considered a normal part of aging.
This study is based on the assumption that FI among nursing home patients can be prevented, cured or ameliorated by offering nursing home staff knowledge of best practise. The primary objective of the study is to test the hypothesis that a multifaceted educational program for staff on assessment and treatment of FI, is associated with a reduction in patients' frequency of FI.
The design of the study is a two armed cluster randomized trail (C-RCT) with a repeated cross-sectional approach.The results will be analysed according to multilevel and longitudinal modelling, and the study will use mixed effect models with the cluster treated as a random effect.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Nursing homes with similar:
- •patients characteristcs
- •care staff/patients ratio
- •general practitioner consultancy
- •All patients on long term care residency (residency >month)
- •Registered Nurses/authorized social educators:
- •All working half time or more
排除标准
- •Nursing homes:
- •With some kind of speciality (eks rehabilitation, dementia)
- •Short term care residency
- •Registered nurses/authorized social educator:
- •Working less than half time
- •Working only night shifts
结局指标
主要结局
Change in frequency of fecal incontinence among patients
时间窗: Baseline, after 3 months and after 6 months
As measured by The Long-Term Care Facilities Assessment System (interRAI-LTCF 2012), section H: Continence. Because of relatively high risk of death and movement out of clusters, a repeated cross-sectional opproach to analyses will be used. Frequency of FI will thereby be analysed on a across-sectional group level.
次要结局
- Change in behavior among health personnel(Baseline, after 3 months and after 6 months)
- Change in FI-related concerns among patients(Baseline, after 3 months and after 6 months)
- Change in knowledge among registered nurses and authorized social educators(Baseline, after 3 months and after 6 months)
- Remission of fecal incontinence among patients(Baseline, after 3 months and after 6 months)
- Correlates of FI among patients(Baseline, after 3 months and after 6 months)